Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor and Blood Cancer Patients

Study Purpose

This will be the first in-depth study to evaluate pretreatment and 12 months post-treatment, neurocognitive and psychological outcomes of children with brain tumor and blood cancer in Pakistan. The investigators will also determine the socioeconomic burden of pediatric brain tumors in low middle-income region and the association of micro RNA and protein markers with neurocognitive outcomes in PBT and blood cancer children. A prospective cohort study with a follow-up of 12 months at the Aga Khan University Hospital, Karachi, Pakistan and Jinnah postgraduate Medical Centre , Karachi, Pakistan will be conducted. After taking consent/ assent the investigators will recruit 80, 5-21 years old children with newly diagnosed brain tumors presenting with any stage, who have not undergone any treatment. Trained psychologist will assess the neurocognitive outcomes by the Slosson scale, Raven's progressive matrices and Wechsler Intelligence Scale for children (WISC V) and Wechsler Adult Intelligence Scale (WAIS-IV) tools. The Quality of life and depression of the children will be determined by PedQL and Revised Children's Anxiety and Depression Scale (RCADS) and hospital anxiety and depression scale (HADs) respectively . The financial burden of the disease on the family will be measured on a visual analog scale ranging from no burden

(0) to very large burden (100) and the parents QoL and disrupted schedule, financial problems, lack of family support, health problems and the impact of caregiving on caregiver's self-esteem will be assessed by Pediatric Quality of Life Inventory PedQl (family module) and Caregiver Reaction Assessment (CRA) tools respectively.

The serum micro RNA (mi-21, mi-10b and mi-210) and protein markers (GFAP, NSE and S100β) will be assessed by qRT-PCR and ELISA.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	5 Years - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 5-21 years children with brain tumor, presenting with any stage. 2. Children residing in Pakistan for at least 3 months. 3. Children accompanied by both or either of the parent. 4. Children with basic understanding of English. 5. Children and their parents who understand and speak in Urdu. 6. Children and their parents who will give assent / consent to participate in the study.

Exclusion Criteria:

1. Children who have received any type of treatment for brain tumor and blood cancer. 2. Children presenting with recurrence. 3. Children with metastatic brain tumor and blood cancer. 4. Known cases of any illness leading to psychiatric/neurological illness (e.g. ADHD, autism, schizophrenia) as confirmed by medical records, will be excluded from the study as they may be on medications that might distort the results. 5. Children with physical comorbidities and debilitating disease. 6. Children who will loss to follow-up. -

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05709522
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aga Khan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Pakistan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor, Pediatric, Blood Cancer

Additional Details

Rationale: The synergy between poverty, socio-cultural, psychosocial and biological risk factors influences neurocognitive outcomes in children. In a LMIC like ours where children are growing up at a disadvantage, it is important the child's future potential and productivity. To the best of the investigators knowledge limited information, there is no data in this area from Pakistan. Data to assess the neurocognitive and psychological outcomes of children during this vulnerable period and to design interventions which may help to improve from this study will be enable the assessment of direction and magnitude of effects, identify high risk children whom would benefit from individual treatment and, with this knowledge, enhance family support Study Design and Site A prospective cohort study with a follow-up of 12 months. The study will be conducted at the Aga Khan University Hospital (AKUH) and Jinnah post graduate Medical Centre (JPMC). The participants will be recruited from the neurosurgery/oncology clinics. Study Participants The study participants will be 5 to 21 years old children with newly diagnosed brain tumors and blood cancer presenting with any stage, who have not undergone any treatment. Sampling strategy Purposive sampling technique will be used for selecting the participants. The target population, that is, brain tumor and blood cancer children who have not received cancer treatment, will be approached by trained psychologist. Sample size: With a mean difference of neurocognitive outcome ranging from 15 to 23 and difference of standard deviation ranging from 14 to 27, from pretreatment to 12 months post treatment .And with a mean difference of Quality of life ranging from 9 to 16 and difference of standard deviation ranging from 18 to 19 . With a power of 80% and level of significance of 5%. However, the investigators calculated the sample size using two population mean in order to compare the mean neurocognitive and psychological scores of the two groups. With an anticipated mean difference of 6, a standard deviation of 15 for the two groups, a level of significance of 5%, and power of 80%. Therefore the final sample size will be 80 patients ( 40 pediatric brain tumor patients and 40 blood cancer patients), with a 10% inflation for loss to follow-up. Data collection The children with brain tumor and blood cancer will be recruited from the surgery/ pediatric oncology clinics AKUH. Screening tool will be administered for eligibility of the study participant for the study. The Pediatric Quality of Life Inventory , PedsQL family information form will be completed by the parents that contains demographic information required to calculate Hollingshead socioeconomic status (SES). Information will also be collected on; tumor and treatment related factors, histopathology, family history, nutritional status, consanguinity and perinatal risk factors and molecular expression analysis chart on a structured questionnaire for pediatric brain tumor patients and blood cancer patients. The neurocognitive outcomes of the eligible children will be assessed by a psychologist at baseline i.e., before treatment and 12 months post-treatment. It will be assessed by the Slosson Intelligence tool Revised 3rd edition (SIT-R3) and Raven's Progressive Matrices (RPM).The progressing speed will be assessed by Wechsler Intelligence Scale for children (WISC V) and Wechsler Adult Intelligence Scale (WAIS-IV) Plan of Analysis Data will be analyzed using STATA version 15. Results will be presented as mean and standard error/ median , interquartile range (IQR) for cognitive outcomes, quality of life (QoL) scores and financial burden scores. Pretreatment and 12 months post treatment scores will be assessed by paired t test/ wilcoxon sign rank test as appropriate. Categorical variables will be reported as frequency and percentages and will be assessed by chi-square/ fisher exact test. Correlation analysis will be preformed to assess relationship of child's neurocognitive outcome scores with QoL scores and child's QoL scores with the parents QoL scores. Unadjusted and adjusted beta coefficient with 95% CI will be reported by using Linear mixed effects models (LMEMs) to determine the association of various independent factors such as child factors (demographic factors), parental factors (educational status, socioeconomic status, prenatal exposure/ infections) , tumor and treatment related factors with the neurocognitive outcomes and QoL. We will adjust for the independent variables and determine the association of factors causing a greater decline in outcomes by multivariable Linear mixed effects models (LMEMs) . Plausible interactions will also be assessed. A p value of < 0.05 will be considered as significant throughout the study

Arms & Interventions

Arms

: Pediatric brain tumor patients

The study participants will be 5 to 21 years old children with newly diagnosed brain tumors presenting with any stage, who have not undergone any treatment

: Blood cancer children

The study participants will be 5 to 21 years old children with newly diagnosed blood cancer presenting with any stage, who have not undergone any treatment

Interventions

Behavioral: - Neurocognitive tools

Neurocognitve and psychological tools

Contact a Trial Team

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